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Job Description

One of our large pharmaceutical clients is looking to hire a 2nd Shift Quality Person In Plant to join the growing External Quality team within Advanced Therapeutics. This individual will be providing Quality oversight of the analytical space. Individuals must be comfortable working 2nd shift onsite between the hours of 1:30-11pm with rotational weekend work.

Main responsibilities will include:

-Review and approve nonconformances and deviations out of specification.

-Interface as liaison internally and externally for review/approval/implementation of change controls.

-Support monitoring of EM quality performance and proactively identify risks.

-Influence and build relationship with internal and external partners to continuously enhance quality performance.

-Interface with other functions i.e. Operations, Planning, Technical Operations, etc. as well as the external manufacturer

-Apply cGMP regulations and other FDA and international requirements to all aspects of the position.

-Provide on-site support as needed on request of the team lead

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

Skills and Requirements

-Bachelor’s degree with a concentration in engineering, science, or an equivalent technical discipline

-Minimum 5+ years of experience working within drug substance or pharma manufacturing space

-Minimum 4-6 years of experience working with analytical methods i.e. flow cytometry within QC manufacturing space

-Solid quality-centric experience and mindset (QA/QC)

-Strong interpersonal skills both written and verbal

-Ability to quickly process complex information and make critical decisions with limited information in a complex and time-sensitive environment

-Experience in biologic or vaccine or cell culture products -Cell and Gene therapy experience